BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZINGER GUIDE WIRE - CRDM

    MDR report key: 3744713 · Received April 11, 2014

    Report

    Report Number
    2182208-2014-01095
    Event Type
    Injury
    Date Received
    April 11, 2014
    Date of Event
    February 12, 2014
    Report Date
    February 12, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DQT
    PMA / PMN Number
    K983927
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE GUIDEWIRE WAS USED TO POSITION THE LEAD IN THE CORONARY SINUS VEIN. THERE WAS DIFFICULTY POSITIONING THE GUIDE CATHETER SO A VENOPLASTY WAS PERFORMED USING THE GUIDEWIRE AS A RAIL OVER WHICH THE VENOPLASTY BALLOON WAS ADVANCED. THE GUIDEWIRE WAS ALSO USED TO TRY AND POSITION THE LEAD OVER THE WIRE TO THE SELECTED VEIN. THIS ATTEMPT WAS NOT SUCCESSFUL AND A SECOND VENOPLASTY WAS PERFORMED. THE SAME TECHNIQUE WAS USED AGAIN TO TRY AND POSITION THE LEAD INTO THE CORONARY SINUS VEIN. THE SECOND ATTEMPT WAS UNSUCCESSFUL; SUBSEQUENTLY, THE LEAD WAS WITHDRAWN AND THEN THE GUIDEWIRE. AS THE GUIDEWIRE EXITED THE GUIDE CATHETER, THE PHYSICIAN NOTED THE WIRE HAD BECOME STRIPPED AND A SMALL THIN STRAND OF WIRE REMAINED IN THE CORONARY VEIN. ATTEMPTS TO REMOVE THE WIRE WITH A SNARE WERE UNSUCCESSFUL. WHEN THE SHEATH WITH THE STRAND WAS REMOVED, THE GUIDEWIRE REMANENT REMAINED VISIBLE IN THE CORONARY VEIN. THE PATIENT SUSTAINED AN AIR EMBOLUS THAT RESULTED IN CIRCULATORY AND RESPIRATORY COLLAPSE REQUIRING RESUSCITATION AND INTUBATION. AT THE END OF THE PROCEDURE, THE PATIENT WAS ON VENTILATORY SUPPORT AND AN INTRAVENOUS PRESSORS INFUSION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222937 ZINGER GUIDE WIRE - CRDM WIRE, GUIDE, CATHETER DQT MEDTRONIC, INC. LVZRXT180S GS657

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Hospitalization| L| R